IP Library Granted Patent US 11,925,364
Granted Patent B2
US 11,925,364 · App. 17/445,044 · Granted Mar 12, 2024

Implant, alignment guides, system and methods of use

Inventors: Albert Dacosta (Lone Tree, CO); Randy Allard (Golden, CO); Richard David Hunt (Arvada, CO); Laura Zagrocki Brinker (Lone Tree, CO); Spanky Raymond (Uniontown, OH)
Assignee: Paragon 28, Inc.
A61B17/1728A61B17/8004A61B17/8057A61B17/842A61B17/86A61B2017/564A61B17/8061A61B2090/08021
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Quick Facts
Patent No.
US 11,925,364
App. No.
17/445,044
Granted
Mar 12, 2024
Kind
B2
Abstract

Bone fusion system, devices, guides, implant and methods for using the bone fusion system, devices, guides and implant are disclosed. The fusion system includes a first alignment guide, a second alignment guide, and an implant. The first alignment guide couples to an intermediate portion of the implant and the second alignment guide couples to a distal portion of the implant. The implant includes a body portion, a first extension portion extending away from a first end of the body portion, a second extension portion extending away from a posterior of the body portion, and a third extension portion extending away from a distal end of the body portion. Finally, methods for using the bone fusion system, devices, guide and implant are disclosed.

Claims (105)

1. A fusion system, comprising:

a first alignment guide, comprising:

a body;

a coupling member engaging a first end of the body;

a fixation member engaging a first end of the body; and

a tissue protector engaging a second end of the body;

a second alignment guide, comprising:

a body;

a fixation member engaging a first end of the body; and

a tissue protector engaging the second end of the body; and

an implant, wherein the first alignment guide couples to an intermediate portion of the implant and the second alignment guide couples to a distal portion of the implant.

2. The fusion system of claim 1 , wherein each body comprises:

an arm extending from the first end of the body to the second end of the body;

an attachment portion coupled to the arm at the first end of the body; and

an alignment portion coupled to the arm at the second end of the body.

3. The fusion system of claim 2 , wherein the attachment portion comprises:

a through hole extending from a top surface of the attachment portion through to a bottom surface of the attachment portion;

wherein the coupling member is received within the through hole from the bottom surface; and

wherein the fixation member extends through the coupling member to engage the implant.

4. The fusion system of claim 3 , wherein the alignment portion comprises:

at least one hole extending through the alignment portion from a first end to a second end.

5. The fusion system of claim 4 , wherein the at least one hole is two holes, and wherein the two holes at least partially overlap.

6. The fusion system of claim 1 , wherein the body comprises:

an arm extending from the first end of the body to the second end of the body;

an attachment portion coupled to the arm at the first end of the body, the attachment portion comprising:

a through hole extending from a top surface of the attachment portion through to a bottom surface of the attachment portion, wherein the fixation member extends through the through hole; and

an alignment portion coupled to the arm at the second end of the body, the alignment portion comprising:

at least one hole extending through the alignment portion from a first end to a second end.

7. The fusion system of claim 6 , wherein the at least one hole is two holes, and wherein the two holes at least partially overlap.

8. The fusion system of claim 1 , wherein the body of the first alignment guide is positioned at a first angle relative to a longitudinal axis of the implant, wherein the body of the second alignment guide is positioned at a second angle relative to the longitudinal axis of the implant, and wherein the first angle is different than the second angle.

9. The fusion system of claim 8 , wherein the implant comprises:

a body portion;

a first extension portion extending away from a first end of the body portion, the first extension comprising:

at least one second through hole; and

a compression slot positioned near a first end of the implant, wherein the at least one second through hole is positioned between the compression slot and the body portion;

a second extension portion extending away from a second end of the body portion, the second extension comprising:

at least one third through hole extending through the implant, wherein the second extension portion extends distally from the body portion; and

a third extension portion extending posteriorly away from the second end of the body portion, the third extension comprising:

at least one fourth through hole extending through the implant, wherein the third extension portion extends posteriorly away from the body portion and second extension portion.

10. The fusion system of claim 9 , wherein the body portion comprises:

at least one first through hole;

a first engagement opening for receiving a portion of the fixation member of the first alignment guide; and

a first alignment opening spaced diagonally from the first engagement opening, wherein the first alignment opening receives an alignment pin of the first alignment guide.

11. The fusion system of claim 10 , wherein the body portion further comprises:

a second engagement opening for receiving a portion of the fixation member of the second alignment guide; and

a second alignment opening spaced diagonally from the second engagement opening, wherein the second alignment opening receives an alignment pin of the second alignment guide.

12. The fusion system of claim 9 , further comprising:

a first fastener, wherein the first fastener engages the first alignment guide to position the first fastener relative to the implant; and

a second fastener, wherein the second fastener engages the second alignment guide to position the second fastener relative to the implant.

13. The fusion system of claim 1 , wherein the fixation members comprise:

a knob; and

a shaft extending away from the knob, wherein the shaft comprises:

a first portion coupled to and extending away from a second end of the knob;

a second portion coupled to and extending away from the first portion, wherein the first portion includes a first diameter, the second portion includes a second diameter, and the first diameter is larger than the second diameter; and

at least one engagement member coupled to and extending away from the second portion;

wherein the at least one engagement member is threaded to engage threads in an engagement opening in the implant.

14. The fusion system of claim 1 , wherein the tissue protectors comprise:

a handle portion;

a shaft portion coupled to and extends from the handle portion;

a tip at a second end of the shaft portion; and

a through hole extending through the handle portion and shaft portion along a longitudinal axis of the tissue protectors;

wherein the tissue protectors extend through at least one hole of an alignment portion of each of the first and second alignment guides.

15. An implant comprising:

a body portion, comprising:

at least one first through hole;

a first engagement opening for receiving a portion of a fixation member of a first alignment guide;

a first alignment opening spaced diagonally from the first engagement opening, wherein the first alignment opening receives an alignment pin of the first alignment guide;

at least one second through hole;

a second engagement opening for receiving a portion of a fixation member of a second alignment guide;

a second alignment opening spaced diagonally from the second engagement opening, wherein the second alignment opening receives an alignment pin of the second alignment guide; and

a compression slot positioned near a first end of the implant, wherein the at least one second through hole is positioned between the compression slot and the body portion;

a first extension portion extending away from a first end of the body portion;

a second extension portion extending away from a second end of the body portion; and

a third extension portion extending posteriorly away from the second end of the body portion.

16. The implant of claim 15 , wherein the second extension portion comprises:

at least one third through hole extending through the implant; and

wherein the second extension portion extends distally from the body portion.

17. The implant of claim 16 , wherein the third extension portion comprises:

at least one fourth through hole extending through the implant; and

wherein the third extension portion extends posteriorly away from the body portion and second extension portion.

18. A method for using a fusion system, comprising:

preparing at least one joint;

inserting fixation wires across the at least one joint;

obtaining a plate;

placing the plate over a first bone and at least one second bone of the at least one joint;

coupling the plate to the first bone and the at least one second bone;

obtaining a first alignment guide;

coupling the first alignment guide to the plate;

inserting a first k-wire through the first alignment guide and across a first joint of the at least one joint;

obtaining a second alignment guide;

coupling the second alignment guide to the plate;

inserting a second k-wire through the second alignment guide and across a second joint of the at least one joint

removing the first alignment guide from the plate;

removing the second alignment guide from the plate;

inserting a first compression fastener across the first joint;

inserting a second compression fastener across the second joint;

removing the k-wire; and

closing an incision.

19. The method of claim 18 , wherein coupling the plate to the first bone and the at least one second bone comprises:

inserting at least one first bone screw through a body portion of the plate and into the first bone;

inserting at least one second bone screw through a first extension portion of the plate and into a second bone;

inserting at least one third bone screw through a second extension portion of the plate and into a third bone; and

inserting at least one fourth bone screw through a third extension portion of the plate and into the third bone.

20. The method of claim 19 , wherein the first compression fastener is inserted through the first joint without contacting the bone screws; wherein the second compression fastener is inserted through the second joint without contacting the bone screws;

and wherein the second compression fastener is inserted through the second joint without contacting the first compression fastener.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Apr 22, 2025
From: ARES CAPITAL CORPORATION
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 070908/0038 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 62354/0016 Recorded Nov 11, 2023
From: MIDCAP FUNDING IV TRUST, AS AGENT
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065548/0364 →
RELEASE OF INTELLECTUAL PROPERTY SECURITY INTEREST AT REEL/FRAME NO. 62354/0006 Recorded Nov 10, 2023
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
Reel/Frame 065548/0313 →
SECURITY INTEREST Recorded Nov 2, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: ARES CAPITAL CORPORATION
Reel/Frame 065448/0214 →
SECURITY AGREEMENT SUPPLEMENT (REVOLVING)) Recorded Jan 11, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FUNDING IV TRUST
Reel/Frame 062354/0016 →
SECURITY AGREEMENT SUPPLEMENT (TERM) Recorded Jan 11, 2023
From: PARAGON 28, INC.; PARAGON ADVANCED TECHNOLOGIES, INC.
To: MIDCAP FINANCIAL TRUST
Reel/Frame 062354/0006 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2021
From: DACOSTA, ALBERT; ALLARD, RANDY; HUNT, RICHARD DAVID; BRINKER, LAURA ZAGROCKI; RAYMOND, SPANKY
To: PARAGON 28, INC.
Reel/Frame 057574/0485 →
Continuity (4)
Continuation PCTUS2020018086 · Feb 13, 2020
Provisional Application 62888431 · Aug 16, 2019
Provisional Application 62805081 · Feb 13, 2019
Related Publication 20220000496A1 · Jan 6, 2022
Cited By (1)
US 12,702,431